There are various drugs and formulations available for treating pain, stress and sleep disorders. Pain is a major symptom in many medical conditions and can significantly interfere with a person's quality of life and general functioning. Pain ranges from mild discomfort or dull distress to acute often unbearable agony and may be generalized or localized. NSAIDs (Non-Steroidal Anti-inflammatory Drugs) such as aspirin, ibuprofen and naproxen, are among the most frequently used prescription and over-the-counter drugs used to alleviate symptoms in acute and chronic inflammatory conditions inducing pain. But patients continue to face the significant challenge of their serious complications like gastrointestinal (GI) and renal adverse effects.
Stress is increasing tremendously, particularly among the urban population resulting in various types of stress related disorders. Numerous treatments are used to overcome stress ranging from aromatherapy to administration of therapeutic drugs. Aroma therapy involves inhalation of essential oils. However, it is observed that inhalation may or may not be suitable to all as it can cause irritation to sensitive mucous membranes and damage the smell receptors inside nose. Prolonged inhalation of concentrated essential oils can cause headaches, vertigo, dizziness, nausea, and lethargy. Thus, such therapy for relieving stress could rather aggravate stress or cause other undesirable effects. Administration of therapeutic drugs by oral or intravenous route needs supervision and intervention of a doctor, posing limitations to their application. Further they have delayed onset of action and adverse side effects for e.g. Benzodiazepines, which may be used to treat stress have potentially addictive effects on the patient.
Insomnia, or sleeplessness, a sleep disorder caused by stress or of other etiology is highly prevalent and affects approximately 30% of the general population. Chronically restricted sleep has today become a widespread and serious problem in our society. Insomnia impairs cognitive and physical functioning and is associated with a wide range of impaired daytime functions across a number of emotional, social, and physical domains and could lead to other disorders and health risks. At present the frontline therapy for insomnia are antihistamines, benzodiazepines and non-benzodiazepines. These drugs have various harmful effects for instance drugs for insomnia are habit forming and are thus harmful to the patient. Newer sleep-inducing drugs include Zolpidem, which again show many side-effects the most important being next-day drowsiness, rebound insomnia, dependency and abuse.
Further, persistent use of drugs leads to patients developing resistance for such drugs and decreases its response to further treatment.
Topical formulations available for the treatment of pain; stress and insomnia are also not devoid of any adverse side effects. For example, salicylate and capsaicin based topical formulations for the treatment of pain are irritants to the skin and both of which are preferably avoided even in trace amounts. Topical preparation of St. John's wort for the treatment of stress may increases skin sensitivity to sunlight and cause rashes. Topical formulations to treat insomnia are not very common and the few tried are generally not found to be very effective.
Thus, the topical formulations available are not very effective for relieving pain, stress or insomnia. On the contrary, the available topical formulations either have side-effects or are not capable of effectively relieving an individual of pain, stress and insomnia.
Therefore, there is a need for a safer composition which can be formulated for topical delivery and can relieve one or more of the conditions selected from pain, stress and insomnia.